Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.

Pain, Measured as Units on a Scale [ Time Frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure. ] [ Designated as safety issue: No ]

Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible

Secondary Outcome Measures:

Length of Cry [ Time Frame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture ] [ Designated as safety issue: No ]

cry video recorded and measured after needle stick until pt stopped crying

Heart Rate [ Time Frame: On average the first hour in the emergency department, at 4 time points during lumbar puncture procedure. ] [ Designated as safety issue: No ]

All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded

Other Name: jtip is the brand name for 1% buffered lidocaine needleless injection

Placebo Comparator: normal saline via needleless injection

needleless injection of normal saline prior to lumbar puncture

Drug: jtip needleless lidocaine injection

All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded

Other Name: jtip is the brand name for 1% buffered lidocaine needleless injection

Detailed Description:

Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.

Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.

Eligibility

Ages Eligible for Study:

up to 90 Days (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

fever in infants less than 3 months

Exclusion Criteria:

toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01224431